Sedation
Conditions
Keywords
ketamine, propofol, procedural sedation, moderate procedural sedation in the ED
Brief summary
This study is a clinical trial of moderate sedation with propofol versus moderate sedation with ketamine for procedural sedation in the Emergency Department.
Interventions
DRUGpropofol
propofol 1 millgram per kilogram intravenous bolus followed by 0.5 milligrams per kilogram as needed for moderate procedural sedation
DRUGKetamine
ketamine milligram per kilogram followed by 0.5 milligrams per kilogram as need for moderate procedural sedation
Sponsors
Hennepin Healthcare Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients who require moderate procedural sedation with propofol in the ED
Exclusion criteria
* age \> 17 years * pregnant * intoxicated * cannot give informed consent * allergy to ketamine or propofol * patient will require deep procedural sedation * ASA physical status score \> 2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Depression (Sub-clinical and Clinical Signs) | From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 minutes) | binary measure based on the occurrence of an oxygen saturation less than 93 at any time, a change in baseline end tidal co2 \>10 or an absence on capnographic waveform |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Return of Baseline Mental Status | from start of procedure until the return of baseline mental status up to 120 minutes | time in seconds from the first dose of medication until the patient has regained baseline mental status |
| Patient Reported Pain or Recall of the Procedure | single measurement immediately after patient returns to baseline mental status after sedation procedure | patient completed question after return to baseline mental status did you feel pain during the procedure and do you remember any part of the procedure answered by circling yes or no on a question sheet, positive if yes to either question |
| Depth of Sedation | single measurement during sedation procedure | Observes assesment of alertness scale, 1-5 ordinal scale measuring level of awareness, one represents awake, 5 general anesthesia/unresponsive to pain |
Countries
United States
Participant flow
Recruitment details
100 patients recruited in the Emergency Department
Pre-assignment details
97 enrolled subjects underwent procedural sedation
Participants by arm
| Arm | Count |
|---|---|
| Propofol propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation | 50 |
| Ketamine ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | did not undergo sedation after enrollmen | 0 | 3 |
Baseline characteristics
| Characteristic | Ketamine | Propofol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 50 Participants | 100 Participants |
| Age Continuous | 30 years STANDARD_DEVIATION 5 | 34 years STANDARD_DEVIATION 5 | 32 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 25 Participants | 24 Participants | 49 Participants |
| Sex: Female, Male Male | 25 Participants | 26 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 47 |
| serious Total, serious adverse events | 0 / 50 | 0 / 47 |
Outcome results
Primary
Respiratory Depression (Sub-clinical and Clinical Signs)
binary measure based on the occurrence of an oxygen saturation less than 93 at any time, a change in baseline end tidal co2 \>10 or an absence on capnographic waveform
Time frame: From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 minutes)
Population: 50 subjects were randomized to each group, 50 subjects in the propofol arm completed the study, 47 in the ketamine arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propofol | Respiratory Depression (Sub-clinical and Clinical Signs) | 0.4 percentage of participants |
| Ketamine | Respiratory Depression (Sub-clinical and Clinical Signs) | 0.6 percentage of participants |
Secondary
Depth of Sedation
Observes assesment of alertness scale, 1-5 ordinal scale measuring level of awareness, one represents awake, 5 general anesthesia/unresponsive to pain
Time frame: single measurement during sedation procedure
Population: 100 patients were randomized, 50 to the propofol group, 50 of whom underwent sedation, and 50 in the ketamine group, 47 of whom underwent sedation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Propofol | Depth of Sedation | 2 score on a scale |
| Ketamine | Depth of Sedation | 2 score on a scale |
Secondary
Patient Reported Pain or Recall of the Procedure
patient completed question after return to baseline mental status did you feel pain during the procedure and do you remember any part of the procedure answered by circling yes or no on a question sheet, positive if yes to either question
Time frame: single measurement immediately after patient returns to baseline mental status after sedation procedure
Population: 100 patients were randomized, 50 to each group, 50 underwent the procedure in the propofol group and 47 in the ketamine group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propofol | Patient Reported Pain or Recall of the Procedure | 0.06 percentage of participants |
| Ketamine | Patient Reported Pain or Recall of the Procedure | 0.02 percentage of participants |
Secondary
Time to Return of Baseline Mental Status
time in seconds from the first dose of medication until the patient has regained baseline mental status
Time frame: from start of procedure until the return of baseline mental status up to 120 minutes
Population: 50 patients were randomized to the propofol group and 50 to ketamine, 50 underwent the procedure in the propofol group and 47 in the ketamine group
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Propofol | Time to Return of Baseline Mental Status | 5 minutes |
| Ketamine | Time to Return of Baseline Mental Status | 14 minutes |